Activities and Participation. (a) Kite shall use Commercially Reasonable Efforts to Commercialize Licensed Products for each Indication after Regulatory Approval is obtained for such Indication in the applicable country. Arcellx shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the Arcellx Commercial Activities under each Core Commercialization Plan. The Parties shall reasonably cooperate to effectuate implementation of Commercialization of Co-Promote Products in the Field in the United States as set forth in each Core Commercialization Plan. The Non-Core Commercialization Plan for each Licensed Product shall at all times include activities commensurate with use of such Commercially Reasonable Efforts. Notwithstanding anything to the contrary contained herein, a Party or its Affiliate shall not be obligated to undertake or continue any Commercialization activities with respect to the Licensed Products if such Party (or Affiliate) reasonably determines that performance of such Commercialization activity would violate applicable Law. (b) Additionally, for each Co-Promote Product in the U.S., each Party shall, to the extent within such Party’s Commercialization responsibilities, use Commercially Reasonable Efforts to: (i) launch the Co-Promote Product in the U.S. promptly after receipt of BLA approval, inclusive of commercial and CMC readiness at the time of such receipt; (ii) establish sufficient Manufacturing capability, CMC readiness, and capacity for launch of the Existing Product (including by performing Manufacturing Transfer to Kite for the Existing Product), sufficiently in advance of commercial launch of the Existing Product and in any event at the time of receipt of BLA approval; (iii) maximize Pre-Tax Profit and Losses for such Co-Promote Product; and (iv) execute the Core Commercialization Plan for such Co-Promote Product. (c) During the Term, Kite, either by itself or its Affiliates or Sublicensees, shall be solely responsible for, all Commercialization activities in connection with the Licensed Products, subject to Section 5.1.3(d) below. (d) With respect to the United States, it is the expectation of the Parties that Arcellx and Kite will both participate in implementing the Commercialization of Co-Promote Products in the Field, with Arcellx undertaking Arcellx Commercial Activities.
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Sources: Collaboration and License Agreement (Arcellx, Inc.)
Activities and Participation. (ai) Kite shall use Commercially Reasonable Efforts to Commercialize Licensed Products for each Indication after Regulatory Approval is obtained for such Indication in the applicable country. Arcellx Each Party shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the Arcellx Commercial Activities activities assigned to it under each Core the Co-Commercialization Plan and the COMPANY Commercialization Plan. The Parties shall reasonably cooperate to effectuate implementation of Commercialization of Co-Promote Products in the Field in the United States Co-Commercialization Territory as set forth in each Core the Co-Commercialization Plan. The Non-Core Commercialization Plan for each Licensed Product shall at all times include activities commensurate with use of such Commercially Reasonable Efforts. Notwithstanding anything to the contrary contained herein, a Party or its Affiliate shall not be obligated to undertake or continue any Commercialization activities with respect to the Licensed Antibody or Products if such Party (or Affiliate) reasonably determines that performance of such Commercialization activity would violate applicable LawLaw or if a Regulatory Authority determines that such Commercialization activities with respect to the Licensed Antibody or Product would pose an unacceptable safety risk to patients.
(bii) Additionally, for each With respect to activities allocated to COMPANY under the Co-Promote Commercialization Plan, COMPANY agrees to reasonably cooperate as MorphoSys may request to provide MorphoSys an opportunity to observe and participate in COMPANY’s and its Affiliates’ performance of such activities.
(iii) Within [***] months after commercial launch of a Product in the U.S.first of the European Major Markets, each Party shall, MorphoSys shall have the right to designate up to [***] representatives of MorphoSys (the extent within "MorphoSys Representatives") to participate in COMPANY’s (or its Affiliates’) strategic planning of Commercialization of Products in the COMPANY Territory [***]. It is the intent of the Parties that any such Party’s Commercialization responsibilities, MorphoSys Representatives shall be an integral part of the team that brings the Products to market in the COMPANY Territory. COMPANY shall use Commercially Reasonable Efforts to:
(i) launch to inform and involve the Co-Promote Product MorphoSys Representatives in the U.S. promptly after receipt of BLA approval, inclusive of commercial and CMC readiness at the time of such receipt;
(ii) establish sufficient Manufacturing capability, CMC readiness, and capacity for launch of the Existing Product (including by performing Manufacturing Transfer to Kite for the Existing Product), sufficiently in advance of commercial launch of the Existing Product and in any event at the time of receipt of BLA approval;
(iii) maximize Pre-Tax Profit and Losses for such Co-Promote Product; and
(iv) execute the Core Commercialization Plan for such Co-Promote Product.
(c) During the Term, Kite, either by itself or its Affiliates or Sublicensees, shall be solely responsible for, all Commercialization activities in connection with the Licensed Products, subject to Section 5.1.3(d) below.
(d) With respect to the United States, it is the expectation of the Parties that Arcellx and Kite will both participate in implementing COMPANY’s internal strategic discussions regarding the Commercialization of Co-Promote Products in the FieldCOMPANY Territory, with Arcellx undertaking Arcellx Commercial Activitiesincluding meetings of COMPANY’s (or its Affiliates’) designated brand value team or equivalent, and to keep the MorphoSys Representatives informed and involved in strategic discussions regarding implementation of Commercialization of Products in the COMPANY Territory.
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Activities and Participation. (ai) Kite shall use Commercially Reasonable Efforts to Commercialize Licensed Products for each Indication after Regulatory Approval is obtained for such Indication in the applicable country. Arcellx Each Party shall use Commercially Reasonable Efforts to execute and to perform, or cause to be performed, the Arcellx Commercial Activities activities assigned to it under each Core the Co-Commercialization Plan and the COMPANY Commercialization Plan. The Parties shall reasonably cooperate to effectuate implementation of Commercialization of Co-Promote Products in the Field in the United States Co-Commercialization Territory as set forth in each Core the Co-Commercialization Plan. The Non-Core Commercialization Plan for each Licensed Product shall at all times include activities commensurate with use of such Commercially Reasonable Efforts. Notwithstanding anything to the contrary contained herein, a Party or its Affiliate shall not be obligated to undertake or continue any Commercialization activities with respect to the Licensed Antibody or Products if such Party (or Affiliate) reasonably determines that performance of such Commercialization activity would violate applicable LawLaw or if a Regulatory Authority determines that such Commercialization activities with respect to the Licensed Antibody or Product would pose an unacceptable safety risk to patients.
(bii) Additionally, for each With respect to activities allocated to COMPANY under the Co-Promote Commercialization Plan, COMPANY agrees to reasonably cooperate as MorphoSys may request to provide MorphoSys an opportunity to observe and participate in COMPANY’s and its Affiliates’ performance of such activities.
(iii) Within [***] months after commercial launch of a Product in the U.S.first of the European Major Markets, each Party shall, MorphoSys shall have the right to designate up to [***] representatives of MorphoSys (the extent within “MorphoSys Representatives”) to participate in COMPANY’s (or its Affiliates’) strategic planning of Commercialization of Products in the COMPANY Territory [***]. It is the intent of the Parties that any such Party’s Commercialization responsibilities, MorphoSys Representatives shall be an integral part of the team that brings the Products to market in the COMPANY Territory. COMPANY shall use Commercially Reasonable Efforts to:
(i) launch to inform and involve the Co-Promote Product MorphoSys Representatives in the U.S. promptly after receipt of BLA approval, inclusive of commercial and CMC readiness at the time of such receipt;
(ii) establish sufficient Manufacturing capability, CMC readiness, and capacity for launch of the Existing Product (including by performing Manufacturing Transfer to Kite for the Existing Product), sufficiently in advance of commercial launch of the Existing Product and in any event at the time of receipt of BLA approval;
(iii) maximize Pre-Tax Profit and Losses for such Co-Promote Product; and
(iv) execute the Core Commercialization Plan for such Co-Promote Product.
(c) During the Term, Kite, either by itself or its Affiliates or Sublicensees, shall be solely responsible for, all Commercialization activities in connection with the Licensed Products, subject to Section 5.1.3(d) below.
(d) With respect to the United States, it is the expectation of the Parties that Arcellx and Kite will both participate in implementing COMPANY’s internal strategic discussions regarding the Commercialization of Co-Promote Products in the FieldCOMPANY Territory, with Arcellx undertaking Arcellx Commercial Activitiesincluding meetings of COMPANY’s (or its Affiliates’) designated brand value team or equivalent, and to keep the MorphoSys Representatives informed and involved in strategic discussions regarding implementation of Commercialization of Products in the COMPANY Territory.
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